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Ensayos clínicos

Ensayos clínicos

A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000942, ACTG 316A
  • Concluido

Propósito del estudio

To evaluate the effect of nevirapine (NVP) versus NVP placebo, administered to HIV-infected pregnant women in labor and to their infants within the first 48 to 72 hours of life, on the incidence of HIV transmission.

Afección:Fase:
Infecciones por el VIH
Embarazo
Fase 3

Detalles del estudio

NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early post-partum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated RT in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk.Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: 1) use of antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all; monotherapy [with no multi-agent therapy] for any duration; multi-agent therapy for any duration), and 2) CD4 cell count at the time of randomization (less than 200 cells; 200 to 399 cells; 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum. Due to the results of ACTG 076 and 185, all women for entry into ACTG 316 are encouraged to incorporate a regimen of zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and to their neonates (for at least 6 weeks post-birth). Infants receive a single oral dose of NVP (or the corresponding placebo) administered between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life, and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.

Criterios de exclusión

    You will not be eligible for this study if: Your baby will not live. You intend to breast-feed. You are allergic to benzodiazepines (a tranquilizer). You have a liver disorder. You have received non-nucleoside reverse transcriptase inhibitors (a class of anti-HIV drugs).

Centros de estudio/contactos

Bahamas

    Princess Margaret Hosp, Nassau, Bahamas

France

    Hopital Hotel Dieu de Lyon, Lyon, France

    CHRU de Nantes, Nantes, France

Italy

    Universita Frederico II, Napoli, Italy

Spain

    Hosp Doce De Octubre, Madrid, Spain

Actualizado: 13 de octubre del 2004

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